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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PATIENT SPECIFIC DISTAL FEMUR REPLACEMENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE PATIENT SPECIFIC DISTAL FEMUR REPLACEMENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 12/06/2021
Event Type  Injury  
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
 
Event Description
It was reported that patient requires a revision due to infection.
 
Manufacturer Narrative
Reported event: an event regarding infection involving a patient specific, distal femoral replacement was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.There have been no other events for the sterile lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It was reported that patient requires a revision due to infection.Update: the request for a siw revision device was cancelled.The sales rep reported "this was revised over christmas by another surgeon to an arthrodesis nail".
 
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Brand Name
PATIENT SPECIFIC DISTAL FEMUR REPLACEMENT
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK  WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK   WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key13115312
MDR Text Key285189964
Report Number3004105610-2021-00164
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K140898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2014
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 18736
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2021
Initial Date FDA Received12/29/2021
Supplement Dates Manufacturer Received03/04/2022
Supplement Dates FDA Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age83 YR
Patient SexMale
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